Yogesh Lokhande, Vice President – Products, Cygnet Infotech, is currently responsible to lead the E-signature business line with products such as Cygnature blockchain-based signing solution and Cygnature bulk signing solution, coordinating the various activities of business development, product development, marketing, partnerships, delivery, and customer support for clients in over 8 countries. He has been with Cygnet Infotech for over 11 years and has played various roles in marketing, sales, and product management. Yogesh is an alumnus of IIM Bangalore and has worked with First Apex, Career Forum, and National Innovation Foundation in the past. He regularly conducts self-awareness workshops and is a certified mindfulness coach, inner game trainer, and zen counselor.
Alpha, Beta, Delta, Omicron and all its 30 odd subvariants like BA.4, BA.5 have hogged the headlines in newspapers and TV channels across the world since the pandemic started. The pharmaceutical industry has been shouldering tremendous responsibility towards developing, testing, and delivering effective vaccines to counter the global threat of Covid-19 virus.
There is no doubt that the pandemic has tsunamied a global wave of digitalization, irrespective of the industry. Digital transformation has become the buzzword in most corporates. Companies have even created special designations and task forces for ushering in the digital workplace.
Digitalization in Pharma Industry
Pharma industry in general has always been resistant to digitalization, due to entrenched ways of working, and the inherent complexity of the drug development and manufacturing processes. However, in the current scenario, digitalization is no longer just a choice, it has become mandatory.
Pharma MSMEs have never been in a better position to take advantage of the situation. The Govt. of India has recently announced a 3-scheme package to boost the sector. This includes Assistance to Pharmaceutical Industry for Common Facilities (APICF), to strengthen the existing pharmaceutical clusters’ capacity for their sustained growth by creating common facilities; Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS) to facilitate growth and development of Pharmaceutical and Medical Devices Sectors through study/survey reports, awareness programs, creation of database, and promotion of industry and most importantly Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) to facilitate Micro, Small and Medium Pharma Enterprises (MSMEs) of proven track record to meet national and international regulatory standards.
Good Manufacturing Practice (GMP)
In most countries, the pharma industry follows a set of manufacturing practices to govern the quality of products. These are called the Good Manufacturing Practices or GMP. Following such practices can help Pharma MSMEs to raise their standards and become acceptable in the global market.
Transforming Documents: From Paper to Digital
Getting started with the digitalization process can be a challenge as well as a rewarding task. Beware of employee resistance and push back since people have been comfortable following traditional processes. It can be somewhat challenging to train people and get them to adapt to the new and advanced digital processes. However, with the right plan and a phased manner of implementation, this can be achieved easily.
Identifying the documents that can be digitalized can be the first step towards an organization wide shift to digital. Starting with internal approval processes is a good option. By doing a proof of concept, you can also identify the potential hurdles and take feedback from impacted stakeholders. Using the initial successes as a benchmark, you can put in a plan in place to bring more documents under the digital format.
Choosing a software as a foundation for digitalization can go a long way to make the journey more comfortable. Using a software can not only do away with the hard copies, but it can also help in ensuring compliance with the rigorous 21 CFR Part 11 FDA regulation for maintaining electronic records and signatures. There are several tools in the market including Cygnature and Docusign which can help in this objective. Ensure that you do a thorough comparison of the alternatives in terms of security, functionality, ease of use and fitment to your process.
After selecting the solution, you must focus on developing awareness of the solution and its workflow within the organization. The solution chosen must be an innovative approach towards digitalization. It should be the easiest of all solutions available at your organization. The solution must be the one that upscales your business on your desired horizons in a year or two. Therefore, defining a digitalization goal for your organization is an important step.
Digital documentation being the first step towards digitalization holds a profound influence on the overall process. It not only strengthens the digital presence in the organization and streamlines the documentation process, but also brings along numerous benefits leading towards better business. To name a few, cost effectiveness, reduction in manual complex procedures, upgradation of traditional methodologies, time saving, and so on.
Going digital helps to build a better brand, set your benchmark with global standards and streamline your business operations to achieve higher efficiency.